Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump

NCT00472134 | Completed DMC

• 1 other identifier: 11-05-22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of a local anesthetic dispensed via a tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the mesh used in the laparoscopic repair of ventral hernias. The goals are:

• reducing postoperative pain from this procedure
• decreasing length of hospital stay
• reducing or eliminating amount of post-operative narcotics used

Conditions

Hernia, Ventral

Keywords

Hernia; Ventral; Laparoscopic Hernia Repair

Outcome Measures

Primary Outcomes (2)

• Place an elastomeric infusion catheter superficial to the mesh at the conclusion of the laparoscopic ventral hernia repair and compare the following to a group that receives a placebo infusion of saline:

  3 months

• Measuring: Visual Analog Pain Scale, Short-Form McGill Pain Questionnaire, Present Pain Intensity, Quantity of narcotic consumption

  3 months

Secondary Outcomes (2)

• Assess differences in postoperative pulmonary mechanics between the treated and nontreated groups by measuring the changes in maximal inspiratory volumes from baseline.

  3 months

• The return of bowel function: Day of Flatus, Tolerating Regular Diet, Length of hospital stay

  1 week

Study Arms (2)

Bupivicaine via Elastomeric pump

ACTIVE COMPARATOR

Bupivicaine via elastomeric pump

Drug: bupivacaine

Placebo via elastomeric pump

PLACEBO COMPARATOR

Placebo via elastomeric pump

Device: On-Q PainBuster pump

Interventions

bupivacaine DRUG

administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.

Also known as: Marcaine

Bupivicaine via Elastomeric pump

On-Q PainBuster pump DEVICE

local anesthetic (bupivacaine) administered via a pain relief system consisting of a 20 gauge soaker catheter attached to an elastomeric balloon pump that is capable of infusing a set volume of local anesthetic over a wide area of surgical site for 2 to 5 days

Placebo via elastomeric pump

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparoscopic ventral hernia repair
• Consent obtained

You may not qualify if:

• Under 18 years
• Allergic to Bupivacaine
• significant liver or renal disease
• Contraindication to PCA
• Current daily opioid usage
• History of substance abuse disorders
• Dx of chronic pain syndrome
• Daily usage of NSAIDs or COX 2 inhibitors

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Hernia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael J. Rosen, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 8, 2015

Record last verified: 2012-01

Locations

US (1)